A GAO report has determined the FDA hasn't routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) released the report Tuesday.
According to the report, from 2005 through 2009, devicemakers initiated 3,510 medical device recalls, 83 percent of which were classified as Class II, meaning use of these recalled devices carried a moderate health risk. The FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has failed to routinely analyze this data and only reacts to individual recalls as they occur. It therefore misses out on a chance to use the information to address the risks presented by unsafe devices.
"[T]he FDA can't tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn't routinely review recall data," Grassley says in a release. "Recalls are typically voluntary, and patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices. Right now, it looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices. Doing so would establish greater accountability for patients."
The GAO recommends the FDA take a more proactive approach to its oversight. More routine analyses of data could help the agency identify trends in the numbers and types of devices being recalled, as well as the underlying causes of the recalls. Such information would provide help the agency identify strategies to address systemic problems with the design or manufacture of individual devices or entire categories of devices.
In addition, the FDA should more consistently implement audit checks of a small portion of customers and device users involved in the recall. Currently, investigators use unclear procedures for implementing and documenting these checks and making their final assessments. They therefore can make inconsistent determinations about whether firms have effectively conducted a recall.
The GAO also points out that the agency lacks clear criteria for determining whether firms have successfully completed recalls, as well as the documents justifying the termination of a recall. This lack of documentation could leave the agency open to future questions about the criteria used to determine whether it fulfilled its duty with regards to a recall.
In a written statement, the FDA says it continually looks for ways to improve the process of recall audit checks and is in the midst of a project to improve the recall process, according to Dow Jones. The program launched in November.
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